FDA Inspection
Mylan Laboratories Limited (FDF-2)Mylan Laboratories Limited (FDF-2) – FDA Inspection, May 26, 2017
Record Details
This FDA Inspection record concerns Mylan Laboratories Limited (FDF-2), with an inspection on May 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Concepcion Cruz (FDA Associated Person)
- Eric L. Dong (Issuing Officer)
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ID · c3b3d8ef-b5cf-4868-ab95-1933bf124403
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012796
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Mylan Laboratories Limited (FDF-2)
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 28, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 9, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Laboratories Limited (FDF-2)
- FDA Inspection 1253435 - 2023-02-03
- FDA Inspection 1122884 - 2020-02-28
- FDA Inspection 1091217 - 2019-04-26
- FDA Inspection 884211 - 2014-05-16
- FDA Inspection 775616 - 2012-03-09
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